Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

NCT04913532 | Completed

• 1 other identifier: 2020-q12
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer. Investigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.

Conditions

Surgery; Adjuvant Radiotherapy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Acute Toxicity

  Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE

  6 months

Secondary Outcomes (2)

• Feasibility of the radiation plan

  19 days

• other acute Toxicity

  0-6 months

Other Outcomes (1)

• Skin toxicity (Cosmetic results)

  0 to 6 months

Study Arms (1)

Hypofractionation with SIB

EXPERIMENTAL

Hypofractionation with SIB

Radiation: Hypofractionation with simultaneous integrated boost

Interventions

Hypofractionation with simultaneous integrated boost RADIATION

Hypofractionation with simultaneous integrated boost

Hypofractionation with SIB

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
• Indication to adjuvant radiotherapy including boost radiotherapy
• Clearly identified primary tumor region preferably by radiopaque clips
• Primary wound healing after breast conserving therapy without signs of infection
• Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
• Written informed consent

You may not qualify if:

• Patients operated by mastectomy
• No indication for boost radiation
• Resection margins positive for disease or insufficient identification of the boost volume
• Indication for radiotherapy of the regional lymph nodes
• History of prior breast or thoracic radiotherapy
• Extended postoperative seroma at the beginning of radiotherapy
• Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
• Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Shijitan Hospital

Beijing, 100038, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Wenjie Ni, MD.

  Beijing Shijitan Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Capital Medical University

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 4, 2021
• Study Start: June 22, 2021
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)